LIFE SCIENCES | Extension to medical device manufacturers for damage caused by defective products

The Directive (EU) 2024/2853 of 23 October 2024,  known as Product Liability Directive (hereinafter, the New PLD or the Directive), which replaces Directive (EEC) 85/374 of 25 July 1985, is particularly relevant to the medical devices sector as it reflects market developments by recognizing that product safety can no longer be assessed without taking into account digital components, software and data. In this respect, by expanding the definition of “product”, the Directive now also includes medical devices not only in the strict sense, but also in the form of software applications, artificial intelligence systems, remote monitoring platforms and other digital services that affect the device’s functioning or safety.

The Directive also introduces the compensability of damage resulting from the loss, destruction or alteration of data not used for professional purposes, a provision of particular importance for medical devices that process patients’ personal data and health data.

From a subjective standpoint, liability no longer rests exclusively with the manufacturer: the range of potentially liable parties is extended to include importers, authorized representatives, fulfilment service providers and, in the absence of other identifiable economic operators, also to distributors and online platforms that present the product as their own. The rationale behind this approach lies in the need to ensure effective protection for the injured party, particularly in cases where production takes place outside the Union and marketing is carried out through digital channels.

These innovations introduced by the New PLD apply to products placed on the market from 9 December 2026, requiring operators in the medical devices sector to undertake a comprehensive review of their compliance strategies, risk management systems and technical documentation.

Newsletter n. 114 – January 2026